Cabozantinib and Nivolumab for Carcinoid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04197310
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    240mg, intravenously, Day 1 and 15 of a 28 day cycle
  • Cabozantinib — DRUG
    40mg, orally, Daily for a 28 day cycle

Study Details

This research study, is studying the combination of cabozantinib and nivolumab in treating advanced carcinoid tumors. \- Carcinoid tumor is another term used to refer to neuroendocrine tumors that arise in organs such as the gastrointestinal tract, lungs, or thymus.

Key Dates

Start date
Dec 26, 2019
Status verified
Jan 2025
Primary completion
Dec 27, 2023
Completion
Jan 31, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Cabozantinib
    The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Cabozantinib will be administered at a dose of 40mg orally, once daily * Nivolumab will be given at a dose of 240mg every 14 days, intravenously Retreat Phase (Optional) * Participants may elect to stop nivolumab and cabozantinib with confirmed CR after at least 24 weeks of treatment. * Participants who elect to stop and then the condition progresses after stopping study treatment may be eligible to resume nivolumab and cabozantinib therapy. * This resumption will be termed as a retreatment second course phase and is available only while the study remains open and the subject meets specified criteria.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 46 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118-
Dana Farber Cancer InstituteBostonMassachusetts02215-

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